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510(k) Data Aggregation

    K Number
    K212318
    Device Name
    IPL Hair Removal
    Manufacturer
    Dongguan Define Beauty Electronic Technology Co. Ltd
    Date Cleared
    2022-01-14

    (172 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan Define Beauty Electronic Technology Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL HAIR REMOVAL (Model: SG-8025) is an over the counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
    Device Description
    The IPL HAIR REMOVAL SG-8025 is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and it's IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.
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